Executive Director, Regulatory Strategy

Job description

**About Us** Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. Led by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020. We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients. At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. **Driven by patients and their families**, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in **being authentic**—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an **eagerness to learn**, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to **winning as a team** with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to **enable the impossible** because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries. These values are the foundation of our work, empowering us to make a real difference, every day. **About the Team** Kardigan’s Regulatory Affairs team is a collaborative and strategic partner in advancing our portfolio of investigational cardiovascular therapies. Working closely with colleagues across Clinical Development, Medical Affairs, Safety, CMC, Quality and other functions, the team translates evolving science and development plans into clear regulatory strategies that support high-quality decisions and productive engagement with global health authorities. We are building a team that combines scientific rigor, sound judgment, and a practical, solutions-oriented mindset. Team members have the opportunity to shape regulatory approaches, establish scalable ways of working, and influence programs at important stages of development. Our work helps Kardigan move with urgency while maintaining the highest standards of quality, ethics, and compliance, ultimately supporting our mission to bring potentially transformative treatments to people living with cardiovascular disease. **Job Overview** Kardigan is seeking an Executive Director, Regulatory Strategy to lead global regulatory strategy across our portfolio of investigational cardiovascular therapies. Reporting to the SVP, Regulatory Affairs, this leader will serve as the regulatory lead on program teams, own the development and execution of regulatory strategy in line with the integrated development plan for late-stage clinical programs, and act as the primary interface with the U.S. Food and Drug Administration while directing ex-US regulatory activities with support from consultants, vendors, and partners. This is a high-ownership role in a fast-paced, entrepreneurial environment. The Executive Director will help define regulatory pathways for investigational therapies, including in indications without established regulatory precedent, and will help build Kardigan’s regulatory capabilities, processes, and team as the portfolio matures. Early priorities include refining program regulatory strategies and health authority engagement plans, establishing regulatory risk registers and regulatory intelligence monitoring, contributing to core regulatory processes and infrastructure, and managing the consultants and vendors supporting the portfolio. Significant regulatory strategy decisions and major agency positions will be developed in partnership with, and subject to alignment with, the SVP, Regulatory Affairs and the Executive Leadership Team. **Main Responsibilities** • Lead the development and execution of the regulatory strategy in line with the integrated development plan for late-stage clinical programs, ensuring alignment with corporate objectives and applicable global regulatory requirements. • Interface with internal and external stakeholders to develop and implement cross-portfolio global regulatory strategies in line with business objectives. • Serve as the primary point of contact with the FDA — including meeting requests, briefing materials, day-to-day correspondence, and responses to information requests — and direct ex-US regulatory activities with support from consultants, vendors, and partners. • Lead preparation and execution of formal health authority meetings (e.g., Type B/C, End-of-Phase 2, and pre-NDA/pre-MAA meetings), including briefing documents and cross-functional rehearsals. • Independently contribute to and/or oversee the planning, compilation, review, approval, and submission of regulatory documents, including initial INDs/CTAs/NDAs/MAAs and amendments or supplements, meeting packages, expedited-program and designation requests where supported by the data (e.g., Breakthrough Therapy, Fast Track), annual reports, and Investigator’s Brochures. • Ensure regulatory documents and submissions are accurate, complete, verifiable, and compliant with applicable FDA, ICH, and global requirements, and that regulatory databases, submission logs, and correspondence logs are maintained. • Provide quality regulatory input and strategic perspective across all stages of drug development — including clinical development plans, protocol design, endpoint strategy, and evidence-generation planning — to support informed decision-making and optimize the company’s regulatory approaches for product development and lifecycle management. • Lead development and maintenance of the labeling strategy, partnering with Clinical Development, Medical Affairs, and Commercial to align on the evidence required to support them and to prepare the organization for labeling discussions with health authorities. • Partner closely with Regulatory CMC to ensure alignment of overall development strategies and integrated, submission-ready regulatory content. • Identify and assess regulatory risks associated with development programs and define approaches to mitigate them; communicate risk assessments, scenario planning, and mitigation strategies to program teams, the SVP, Regulatory Affairs, and the Executive Leadership Team, surfacing risks early with clear, well-reasoned recommendations. • Directly oversee regulatory responsibilities outsourced to CROs, consultants, and vendors, ensuring quality, strategic alignment, and compliance with applicable regulations and guidelines; provide regulatory due diligence and strategic input for business development opportunities as needed. • Review, write, and present guidelines and SOPs as needed to support high-quality submissions and ensure cross-functional adherence to regulatory requirements. • Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration; monitor, interpret, analyze, and disseminate regulatory intelligence that may affect ongoing development. • Hire, develop, and mentor regulatory professionals, fostering accountability and a culture of collaboration. **About You** **Basic Qualifications** • Bachelor of Science in a scientific discipline. • Minimum of 10 years’ experience in pharmaceutical regulatory activities, with experience as a leader accountable for global regulatory product strategy. • Extensive experience developing and implementing complex regulatory strategies, leading and managing regulatory teams, regulatory submissions (INDs, NDAs, and MAAs), product lifecycle management, and Health Authority interactions. • Matrix leadership: proven ability to lead cross-functional teams across clinical, regulatory, biometrics, data management, clinical operations, and commercial driving alignment on a unified development plan while safeguarding scientific and analytical integrity. • Must have excellent verbal and written communication skills, demonstrating the ability to communicate complex ideas in an easily understandable way. • Hands-on professional capable of working collaboratively and independently. • Excellent planning, organization and time management skills, including the ability to support and prioritize multiple projects. • Demonstrated management experience, including leadership and development of employees. • Current and strong working knowledge of regulatory requirements including GxP, eCTD submission standards, and ICH guidelines. **Preferred Qualifications** • Advanced degree in a scientific discipline. Exact Compensation may vary based on skills, experience and location. Pay range $266,000—$346,000 USD